Mutation of breast cancer gene can be patented, says Federal Court

Amy Corderoy

Cancer survivors and advocates are devastated at a decision by the full bench of the Federal Court that private companies have the right to control human genes.

They fear the decision in the so-called "breast cancer gene" case, which found a company could patent mutations in the gene BRCA1, will lead to higher costs for patients in need of potentially life-saving tests.

Yvonne D'Arcy, who fought to have the breast cancer gene patent overturned, outside the Federal Court in February last year. Photo: Peter Rae

They have called on the federal government to intervene to change the laws, and Maurice Blackburn, the lawyers that brought the case, have vowed to fight it "to the end", flagging a potential appeal to the High Court of Australia.

However, patent lawyers say the laws are a fair reflection of the work done by the biotechnology industry, and the decision may draw business to Australia.

The structure of the protein produced by the BRCA1 gene. Photo: Supplied

Sally Crossing, from Cancer Voices Australia, said the Australian community had made it clear the patenting of human genes was "offensive and counter-intuitive."

"This news is not good for cancer research, especially in the promising field of targeted therapies, or for people affected by any cancer," she said.

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Director of Advocacy at Cancer Council Australia, Paul Grogan, said that, if the ruling was an interpretation of the law, then the law needed to change.

"In 2008, Australian women were only protected from an attempted commercial monopoly over the BRCA1 and BRCA2 tests because the company that threatened to take those tests away from public laboratories withdrew its patent claims voluntarily," he said.

"There was nothing in the law to protect healthcare consumers ... and there still isn't.

He said Australia might now end up finding US companies enforcing patents here that they could not enforce in their home country after a Supreme Court ruling there that overturned the gene patents.

Krystal Barter, who carries a BRCA mutation and founded the charity Pink Hope, said she was uneasy that US company Myriad Generics still owned the gene and the breast cancer risk test.

"I hope to see the case prevail and for our genes to become our own again," she said.

Private companies in Australia cannot be granted patents, which are the exclusive right to exploit new inventions, over naturally occurring things.

It is a win for Myriad, and the owner of the Australian licence for the test, Genetic Technologies. In a statement law firm Jones Day, which acted for Myriad in Australia, said patents drove innovation. "Myriad invested hundreds of millions of dollars in research and development, patient and physician education, insurance reimbursement and operational excellence in laboratory operations which has resulted in a gold standard test, BRACAnalysis, for the testing of predisposition to hereditary breast and ovarian cancer risk at an affordable cost".

Bernadette Hawkins, a patent and trademark attorney at law firm Cullens, said she was not surprised the verdict had been upheld.

"That isolation [of the gene], does produce something that is not inherent in the human body, it is a different structure in the sense it is not surrounded by the things it is in the cell with," she said. "This decision is also certainly not going to stifle research and innovation in this field, in fact, I wonder if we will see more US companies starting to try to commercialise things here".

And Biotechnology consultant Andrew Coley said: "In the current commercial environment of translational scientific research the irony is that commercial exploitation of cancer-causing gene mutations is the only way forward in getting diagnostic tests developed that identify those individuals that carry the mutations".

But Rebecca Gilsenan, the principal lawyer at Maurice Blackburn, which fought the case on behalf of cancer survivor Yvonne D'Arcy, said the patent was granted on a gene that was exactly the same inside as it was once it had been isolated, save for the fact it was not in the body.

"We say [given that] it would not be, from a legal perspective, patentable."

The only way to overturn the decision would be if the firm was granted leave to appeal to the High Court, or if the law was changed.

"Yvonne D'Arcy is not the only person affected by this issue … this issue has far-reaching effects for Australia," she said.

"We are extremely disappointed that the Federal Court has made this decision ... [but] this is such an important issue that we are determined to take it to the end."

Ms D'Arcy said she was confident in the end the law would be changed. "I'm not doing this for me, I'm doing this for all the people I know with cancer and breast cancer, and for the future generations," she said.

An intellectual property consultant, Luigi Palombi, said the decision was based on technicalities springing from another court decision in 1956. That case involved deciding whether a new method of spraying crops was able to be patented.

"It's a very black-letter approach," he said. "[The case they are basing their decision on] is more than 50 years old, and has nothing to do with biotechnology."